Electrical barrier and moisture seal for an implanted medical device

ABSTRACT

Multiple seals, internal to a connector block, provide for connecting an implantable medical device and an implanted cable or lead. The forces to engage sealing or releasing the seals are derived from a mechanism so they can be relaxed to permit ease of insertion or withdrawal of a lead, or can be increased to tightly seal against fluid migration, and to provide an electrical insulation between adjacent conductors of the lead and connector block. During implant of the medical device, the lead is inserted and a shaft is rotated with a tool to engage the seals. Later, the seals can be released by rotating the control shaft in the opposite direction to allow extraction of the lead from the connector block. The seals therefore are able to provide improved sealing without increasing the insertion or the extraction forces for the lead.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part (“CIP”) application of U.S.application Ser. No. 12/061,246, filed Apr. 2, 2008, now issued as U.S.Pat. No. 7,690,953 on Apr. 6, 2010, entitled “A Stackable ElectricalConnection Apparatus”, which claims benefit under 35 U.S.C. §119(e) toU.S. Ser. No. 60/915,765, entitled “Electrical Connection Apparatus”,filed May 3, 2007, and this application claims priority to U.S.Application No. 61/242,460, entitled “Electrical Barrier and MoistureSeal for an Implanted Medical Device,” filed Sep. 15, 2009. The contentof each application is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

Disclosed herein are apparatuses for connecting a lead or catheter to animplantable medical device, and in particular, are connectingapparatuses for isolating and protecting the conductive components ofthe lead or catheter from body or other fluids.

BACKGROUND

Active medical devices for delivering stimulation therapy to body organssuch as the heart, brain, or other tissues are typically comprised oftwo major components. One component is an electronic circuit and powersource, typically a battery, housed in a hermetically sealed container,often referred to as the implantable pulse generator (IPG), or as the“can”. The container includes feed-throughs allowing electrical signalsand power to pass through the hermetic containment in and out of thecircuitry to the second major component, the lead. This lead carrieselectrical signals from the IPG to the target body tissue in order todeliver therapy. The lead may also house conductors that carry signalsgenerated by the human body back to the IPG.

The connection between the IPG and the lead is made in a so called“connector block” or also known as a “header”, which is attached to thebody of the IPG. The connector block is commonly formed from plastic orother materials. It houses the structures to electrically connect thelead's conductors to the corresponding contacts in the connector block.The connector block also has structures that mechanically secure thelead so that it does not move once it is secured. Providing a connectorblock facilitates the establishment and maintenance of a stable, lownoise electrical connection between the IPG and the leads. In additionto providing the electrical connection between devices, connector blocksmay include sealing components that provide isolation between electricalcontact structures. However, some apparatuses for providing anelectrical connection may not physically lock the connection in place ormay not secure the lead position to an extent desired. For example, someleads may be loosely fitted on or in an electrical connection apparatus,and as a result, forces exerted on the lead such as pulling or twistingforces associated with muscle movement, etc. may cause the lead toloosen, create increased signal noise or completely disconnect from theelectrical connection apparatus.

In addition, the conductors within the lead are exposed at electrodesites on the distal end of the lead and interface by direct contact withbody tissues. At the proximal end of the lead, the conductors are againexposed. Various forms of metallic rings, or segments, or end protrudingpins are used to make the conductors available at the outer surface ofthe lead. The proximal end of the lead is inserted into the receptacleof the IPG and the lead's conductors are aligned with mating conductivesurfaces inside the receptacle.

The human body is a hostile environment to implanted medical devices andmaterials. Conductive, corrosive or otherwise interfering body fluidscan compromise the insulation between conductors in the connector block.Thus, long-term implanted connections have seals incorporated intoeither the body of the lead, or in the structure of the connector block.The seals perform two related functions. The seals are a barrier to theintrusion of body or other fluids while the device is chronicallyimplanted subcutaneously. In the absence of seals these fluids maymigrate by various methods, such as capillary action, to the internalsof the receptacle. The seals also separate any existing fluids that mayhave migrated into the connector block during implantation surgery, orthereafter, by making a tight and insulatory fit between the outersurface of the lead and the walls of the lumen in the connector blockshaped to be a receptacle for the proximal end of the lead.

There are two competing requirements for the seals. A tight seal isneeded in order to prevent moisture migration; but must not causefrictional or inertial forces that prevent the insertion of the proximalend of the lead into the receptacle of the connector block. Typically,the requirement for reasonable forces to both insert and to withdraw thelead means both the moisture control attributes of the seals and theelectrical insulating properties must be compromised.

Accordingly, there is a need to provide an electrical connectionapparatus that couples to implantable leads and that provides sealingproperties that block undesirable fluids from entering the electricalconnection apparatus.

SUMMARY

Provided herein is an active implanted medical device having bothenhanced moisture barrier properties and electrical insulatoryproperties of seals incorporated into the body of the receptacle of theactive implanted medical device.

Multiple seals, internal to a connector block or electrical connectionapparatus, provide for sealing the implantable medical device and animplanted cable or lead. The forces to engage sealing or releasing theseal are derived from a mechanism so they can be relaxed to permit easeof insertion or withdrawal of a lead, or can be increased to tightlyseal against fluid migration, and to provide an electrical insulationbetween adjacent conductors of the lead and connector block. Duringimplant of the medical device, the lead is inserted and a shaft may berotated with a tool to tighten a cinch around the seals. The seals maybe released by rotating the control shaft in the opposite direction toloosen the cinch and allow extraction of the lead from the connectorblock. The seals therefore are able to provide improved sealing withoutincreasing the insertion or the extraction forces for the lead. Othermethods of mechanical engagement may also be used. The shaft whichrotates and engages the seals may be the same shaft that engages theelectrical contacts in the device, or the shaft may be dedicated to theseals. Additionally, where the connector block accommodates more thanone lead, a common shaft may engage all contacts and sealssimultaneously, or a shaft may be dedicated to each lead.

In particular, connector blocks may establish the connections by usingeccentric shafts and contacts configured to allow an engaging orlatching of the lead into the connector block.

According to certain embodiments, an electrical connection apparatusincludes at least one stackable block operably coupleable to anotherstackable block, at least one pin receiving portion defined by an innerwall within the stackable block, at least one electrical connectioncontact having a first portion disposed within the at least one pinreceiving portion of the at least one stackable block for receiving apin, and a second portion disposed at a location exterior to thestackable block, where the first portion and the second portionintegrally form the at least one electrical connection contact, and afluid seal arranged in the stackable block adjacent to the electricalconnection contact. The fluid seal includes a seal tube defining a pinreceiving portion for receiving the lead pin and a cinch for reducingthe diameter of the seal tube around the pin. When the diameter of theseal tube is reduced around a diameter of the pin, the seal tube fluidlyisolates the at least one electrical connection contact associated withone stackable block from another electrical connection contactassociated with the another stackable block.

In other embodiments, an electrical connection apparatus includes aplurality of stackable blocks operably coupleable to each other, atleast one pin receiving portion defined by an inner wall within one ofthe plurality of stackable blocks, at least one electrical connectioncontact with a first portion arranged in the at least one pin receivingportion of the one stackable block and for receiving a pin, and a secondportion disposed at a location exterior to the one stackable block,where the first portion and the second portion integrally form the atleast one electrical connection contact, and a fluid seal arranged inanother of the plurality of stackable blocks. The fluid seal includes aseal tube defining a pin receiving portion for receiving the lead pin,and a cinch for reducing the diameter of the seal tube around the pin.When the diameter of the seal tube is reduced around a diameter of thepin, the seal tube fluidly isolates the at least one electricalconnection contact associated with the one stackable block from theanother stackable block having the fluid seal.

While multiple embodiments of the present invention are disclosedherein, still other embodiments of the present invention will becomeapparent to those skilled in the art from the following detaileddescription, which shows and describes illustrative embodiments of theinvention. As will be realized, by those of ordinary skill in the artupon reading the following disclosure, the invention is capable ofmodifications in various aspects, all without departing from the spiritand scope of the present invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is cutaway view of one embodiment of an electrical connectionapparatus.

FIGS. 2A-B depict a first side and a second side of a connector block.

FIGS. 3A-B depict electrical connection contacts according to certainimplementations.

FIGS. 4A-B depict a first and second side of a connector block with fourelectrical connection contacts according to certain implementations.

FIGS. 5A-5F depict additional embodiments of electrical connectioncontacts.

FIG. 6 depicts a seal component according to certain implementations.

FIG. 7 depicts a seal component according to another implementation.

FIGS. 8A-8D depict additional embodiments of seal components.

FIG. 9 depicts an alternative embodiment of an electrical connectionapparatus having stackable connector blocks.

FIG. 10 depicts an electrical connection apparatus according to anotherimplementation.

FIGS. 11A-C depict a block of the apparatus depicted in FIG. 10.

FIGS. 12A-B depict a first and second sides of a cam component.

FIG. 13 depicts a cross-sectional view of the an electrical connectionapparatus according to an alternative configuration.

FIGS. 14A-B depict a first and second perspective view of anotherelectrical connection apparatus according to certain implementations.

FIGS. 15A-F depict perspective views of a first and second side of afirst end block, a stackable block and a second end block of theapparatus of FIGS. 14A-B.

FIGS. 16A-B depict perspective views of a first and second side of astackable block with a segmented contacting pin in place.

FIGS. 17A-B depict perspective views of the slider and contact in boththe insertion and contact position relative to the pin.

FIGS. 18A-B depict perspective views of a first and second side of a camaccording to certain implementations.

FIGS. 19A-B depict perspective views of electrical connection contactsfor use on a left and a right side of the stackable block.

FIGS. 20A-B depict perspective views of a first and second side of aslider for use with the stackable block.

FIGS. 21A-B depict perspective views of a first and second side of thestackable block with a seal plate.

FIGS. 22A-B depict perspective views of a first and second side of theseal plate depicted in FIGS. 21A-B.

FIGS. 23A-B depict perspective views of a first and second perspectiveview of another electrical connection apparatus having a two pinconfiguration.

FIG. 24 is a flowchart of a method for electrically connecting animplanted medical device and an implanted stimulation electrodeaccording to the present invention.

FIG. 25 is an isometric view of an active seal, according to certainembodiments.

FIG. 26 depicts a proximal end of an implanted lead.

FIG. 27A is an isometric view of a two lumen active seal incorporating acontrolling mechanism, according to certain embodiments.

FIG. 27B is a magnified view of the active seal mechanism, according tocertain embodiments.

FIG. 27C is a magnified view of the active seal mechanism with the camrotated to the latched position.

FIG. 28A is a cross-sectional view of a connector block assembly for animplantable device having a controlling mechanism for engaging seals andelectrical contacts, according to certain embodiments.

FIG. 28B is a cross-sectional view of a connector block assembly for animplantable device having separate controlling mechanisms for engagingseals and electrical contacts, according to certain embodiments.

FIG. 29 is a schematic view of an alternative method of operating theseal

DETAILED DESCRIPTION

The present invention, according to one embodiment, is an electricalconnection apparatus.

In one aspect, an electrical connection apparatus may be used inconjunction with implantable medical devices such as neurostimulators orpacemakers. For example, such an apparatus may be used to provide anelectrical connection between the implanted device and an implantedstimulation electrode. In one embodiment, the implanted device is apacemaker. Alternatively, the implanted device may be an implantablecardioverter defibrillator (“ICD”), an implantable pulse generator, orany other implanted device requiring an electrical connection.

FIG. 1 is a cutaway view of one embodiment of an electrical connectionapparatus 10. The apparatus is comprised of stackable blocks 12 operablyconnected in a stacked fashion, with end blocks 14, 16 disposed at eachend. Each block 12, 14, 16 defines pin receiving portions 18 configuredto receive a pin such as pin 20 depicted in FIG. 1. In addition, a sealcomponent 22 is disposed between each block 12,14,16. Each block 12, inthis implementation, also has electrical connection contacts 24 havingexterior contact points 26 (also referred to herein as “leads”) disposedon an exterior portion of the device 10 and integrally formed C-shapedinterior contact portions 28 disposed within the pin receiving portions18.

Generally, the connection apparatus 10 depicted in FIG. 1 connects twodevices or components in the following fashion. The pin 20, which iselectrically coupled to one device via the lead wires 30, is positionedin one of the pin receiving portions 18 and thereby contacts one or moreof the interior contact portions 28 of the electrical connectioncontacts 24. The other device is positioned or configured such that itis in electrical contact with one more of the exterior contact portions26 of the electrical connection contacts 24. Thus, the two devices areelectrically coupled to each other via the electrical connectionscontacts 24 disposed within each block 12 of the apparatus 10.

In the embodiment depicted in FIG. 1, the apparatus 10 has eightconnector blocks 12. However, it is understood that the apparatus 10 maybe comprised of one block 12, two blocks 12, or any number of blocks 12in order to provide a connection device 10 with the desired size andconfiguration. End blocks 14, 16 may be used as the end termination foreach end of the electrical apparatus 10. End block 14 is also referredto herein as an “insertion end block,” while end block 16 is alsoreferred to herein as an “end cap block.” The blocks 14, 16 may bemanufactured out of metals such as titanium, stainless steel or otherbiocompatible metals or metallic alloys. Alternatively, the blocks 12,14, 16 may be made of biocompatible thermoset or thermoplastic resins,or any other known biocompatible material for use in connection devices

According to the implementation depicted in FIG. 1, the insertion endblock 14 defines mechanical fastening ports 32 for each of the pins 20.Each port 32 may be configured to be in communication with one of thepin receiving portions 18 such that each port 32 may receive a fasteningcomponent (not shown) that may be used to fasten or otherwise secure thepin 20 into its position in that pin receiving portion 18. In oneembodiment, the fastening component is a threaded set screw made frombiocompatible material and each port 32 is a threaded hole configured toreceive such a set screw. Alternatively, any known fastening componentmay be incorporated into the insertion end block 14. In oneimplementation, a cap or other type of cover may be provided andpositioned over the fastening port 32, thereby presenting a relativelysmooth external profile for the device 10. In a further alternative, theinsertion end block 14 has no fastening ports or fastening components,and the pin 20 is at least partially secured within the pin receivingportions via frictional forces created by contact with the C-shapedcontact portions 28.

In use, and in accordance with one aspect, after the pin 20 ispositioned in the pin receiving portion 18, the set screw is threadedinto the port 32 such that the set screw contacts the pin 20 at anelectrically isolated portion of pin 20, and secures pin 20 in the pinreceiving portions 18. It acts to supplement the frictional forcesexerted by the C-shaped contact portions 28 and helps prevent outwardmigration of the pin from the housing caused by vibration or excessivetensile or torsional forces on the pin 20 or lead wires 30 during use.

In one implementation as shown in FIG. 1, pin 20 haselectrically-isolated circumferential contacts 34 distributed along itslength. When the pin 20 is positioned in a pin receiving portion 18,each of the circumferential contacts 34 are positioned to correspondwith and contact a C-shaped contact portion 28. Each circumferentialcontact 34 is electrically connected to one of the lead wires 30, eachof which is embedded in the pin 20. Each individual wire or lead 30 maybe potted within the pin 20 and may be electrically isolated andinsulated from other leads. The pin 20 may contain one or more separateisolated lead wires 30 for each contact 34. Each wire 30 may be capableof maintaining signal integrity from the circumferential contact area 34through the wire 30 and to a desired location within the body, such as atarget tissue, nerve, or some other target area. In one embodiment, awire 30 terminates with a specialized electrode (not shown) to improvesignal delivery to the desired location.

The configuration of a connector block 12 with electrical connectioncontacts 24, according to one embodiment, is shown in FIGS. 2A, 2B, 3,4A, and 4B. FIGS. 2A and 2B depict both sides of a connector block 12without electrical connection contacts, with FIG. 2A depicting a firstside and FIG. 2B depicting a second side. The block 12 has a housing 40that defines the pin receiving portions 18 and further defines slots orpassages 42 in which portions of the electrical connection contacts maybe disposed.

FIG. 3 depicts an electrical connection contact 24, in accordance withone implementation. The electrical connection contact 24 in thisembodiment has a C-shaped contact portion 28 and an external leadportion 26. The contact portion 28 and lead portion 26 are connected viathe link portion 44. In one embodiment as shown in FIG. 3, the C-shapedcontact portion 28 defines slots or gaps. Alternatively, the contactportion 28 is a continuous, solid component with no slots or gaps.

FIGS. 4A and 4B depict a first and second of connector block 12 withfour electrical connection contacts 24, according to certainembodiments. Each electrical connection contact 24 may be positionedsuch that the C-shaped interior contact portion 28 is disposed within apin receiving portion 18, the exterior contact portion 26 may bedisposed on an exterior portion of the housing 40, and the link portion44 may be disposed in one of the slots 42 as discussed above withrespect to FIGS. 2A and 2B.

Each of the contact portions 28, according to one embodiment, isconfigured to contact any pin positioned in the pin receiving portion18. In one embodiment, each contact portion 28 contacts a correspondingpin contact area 34 on the pin 20. Such contact results in an electricalconnection between the lead 30 and the exterior contact points 26, viathe electrical path from the lead 30 to the pin contact area 34 to thecontact portion 28 to the link portion 44 to the exterior contactportion 26.

In accordance with one implementation, each C-shaped contact portion 28is configured to have elastic properties and to have an unconstraineddiameter (also referred to as its “unconstrained position,” “naturalposition,” “starting position,” or “original position”) that is smallerthan the outside diameter (“OD”) of the pin 20. “Elastic properties” asused herein means capable of recovering shape after deformation. Thus,when a pin 20 is positioned in the pin receiving portion 18, the contactportion 28 is deformed from its unconstrained diameter to a largerdiameter that accommodates the pin 20. The elasticity of the contactportion 28 urges it back toward its unconstrained diameter such that thecontact portion 28 is forced into contact with the pin 20 and results ina normal force being exerted across the contact interface. According toone embodiment, the contact portion 28 is forced into contact with acircumferential contact portion 34 on the pin 20. When the pin 20 isremoved, the elastic properties of the contact portion 28 cause thecontact portion 28 to return to its unconstrained diameter.

In another embodiment, the C-shaped contact portion 28 also has amaximum diameter that is limited by the diameter of the pin receivingportion 18. That is, the contact portion 28 may only expand to itsmaximum diameter, at which diameter the contact portion 28 is in contactwith the walls of the pin receiving portion 18 and cannot expandfurther.

FIGS. 5A-5F depict additional embodiments of electrical connectioncontacts.

According to one embodiment, the electrical connection contacts are madeout of a precious metal. For example, the contacts may be constructed ofa platinum or PGM (Platinum Group Metal) alloy such as, but not limitedto, Pt-10% Ir, Pt-20% Ir, Pt-8% W, Paliney® 500, Paliney® 1100, orPaliney® 1200. Alternatively, the contacts may be formed out of a basemetal such as a copper alloy or stainless steel that is overplated withan appropriate electrically and environmentally stable contact materialsuch as Au, Pt, Pd, Pd—Ni, etc. It is also envisioned that the overplatemight cover the entire connection 24 or just the terminal contacts 26,28. According to one embodiment, one advantage of precious metal contactsurfaces in comparison to other conductive materials is that theprecious metal contact surfaces are capable of maintaining stableelectrical signal integrity at reduced force levels. This results inreduced force requirements at the mating of the contact portion 28 andthe pin 20, thereby allowing for greater design flexibility in selectingthe spring characteristics of the contact member 28. Alternatively, theelectrical connection contacts may be made out of a non-PGM metal suchas stainless steel, niobium, tantalum, MP35N, or other such non-PGMmetals. Certain of these non-PGM metals may require higher contactforces to maintain a stable interface, which may be accomplished byselecting a material with a higher elastic modulus and/or a higher yieldstress or by increasing the thickness of the spring member.

The seal component 22, as depicted in FIG. 1 according to oneembodiment, is configured to be disposed between any two blocks(including the end blocks) and operates to create two seals. The firstseal is a seal between the pin 20 and the rest of the block 12. Thesecond seal is a seal between two connected blocks 12 and associated pincontact areas 34.

FIGS. 6 and 7 depict a seal component 22, according to anotherembodiment. In the embodiment depicted in FIG. 6, a seal plate 50 havingfour seal components 22 is positioned on one side of a connector block12. Each seal component 22 disposed in the plate 50 has a “vertical”seal 52 and a “horizontal” seal 54 that completely encircle the pin 20receiving portion 18 of the block 12. The terms “vertical” and“horizontal” are used solely to describe the seals with respect to eachother and the connector blocks and are not intended to be limiting. Itis understood that the vertical seal 52 could also be positionedhorizontally and that the horizontal seal 54 could also be positionedvertically, depending on the disposition of the entire block. Thecombination of seals 52 and 54 result in a t-shaped seal component.

As best shown in FIG. 7, the vertical seal 52 of seal component 22arranged in seal plate 50 provides a seal between the pin receivingportion 18 and the areas exterior to the pin receiving portion 18. Inone embodiment, one end 56 of the vertical seal 52 contacts the block 12next to which the plate 50 has been positioned and the other end 58 ofthe seal 52 contacts the adjacent block 14. According to one embodiment,the vertical seal 52 may form a seal that prevents body fluids fromentering into the pin receiving portion 18, which may cause a short. Inaccordance with one implementation, the horizontal seal 54 of sealcomponent 22 contacts any pin positioned in the pin receiving portion 18and thereby provides a seal in the pin receiving portion 18 betweenblocks 12 and 14. As depicted by the positioning of seal plates 50 inFIG. 7, and in view of the discussion above, it should be understoodthat seal plate 50 may also be provided between adjacent stackableblocks 12 and between blocks 12 and 16.

FIGS. 8A-8D depict additional embodiments of seal components. As shownin FIG. 8C, certain seal plates define a central opening 60. In certainembodiments, this central opening 60 may define a portion of a boltshaft configured to receive a rotating cam or an assembly bolt, both ofwhich are described below. Alternatively, certain seal plate embodimentssuch as that depicted in FIG. 8D have no central opening.

In one embodiment, a seal component is made out of biocompatible,compliant thermoset or thermoplastic polymer, such as, but not limitedto, a silicone rubber. Alternatively, the seal component may be made ofany known compliant biocompatible material that may be used forproviding a seal in a medical device.

FIG. 9 depicts an alternative embodiment of a connector apparatus 80having stackable connector blocks 82. In this embodiment, each block 82has a D-shaped configuration and defines nine pin receiving portions 84.Alternatively, the block 82 may define any number of pin receivingportions that will fit on the block 82 and operate to provide anelectrical connection. It is understood that the blocks 82 and pinreceiving portions 84 may also have any other configuration. That is,the blocks 82 might be formed in another shape and/or the pin receivingportions 84 might be arranged in any other configuration on the blocks82. It is also understood that any of these alternative embodimentscould incorporate any of the various components described herein.

In a further alternative, the stackable blocks are secured in anotherfashion. That is, according to one embodiment, in the absence of the camassembly, the blocks may be secured via a bolt that is disposed througha central hole in each of the stackable blocks 12 and the insertion endblock 14. One example of such a central hole 60 is depicted in FIG. 8C.According to one embodiment, the bolt may be secured to the end block 16via a mating feature. For example, the bolt may have a threaded end thatmates with a threaded hole in the end block 16. Alternatively, any knowncomponents for securing such a bolt to an end block may be used. Thebolt may be fabricated from a high strength biocompatible material suchas stainless steel, a titanium alloy, a Co—Cr alloy such as MP35N, anInconel alloy, or any other known high strength biocompatible material.In one implementation, the proximal portion of the bolt has a drivemechanism to allow for proper tightening on the assembly and may alsohave an over cap to minimize potential exposed surface crevices afterassembly. In one embodiment, the bolt is the only feature for securingthe blocks together. Alternatively, the bolt may be used in conjunctionwith the external clip 110.

FIG. 10 depicts an electrical connection apparatus 100, according toanother embodiment. This apparatus 100 provides for easy insertion andremoval of contact pins. The apparatus 100 has four pin receivingportions 104 defined within the blocks 102 of the apparatus 100. Asdiscussed above with the embodiment depicted in FIG. 1, the pinreceiving portions 104 are disposed through almost the entire length ofthe device 100. A pin (not shown) may be inserted into each of the pinreceiving portions 104 and once activated, will be placed in contactwith each of the C-shaped contact points 108 (see FIG. 11A) as describedbelow. As in the previous embodiment depicted in FIG. 1, each pin hasinternal wires or leads that are electrically connected to thecircumferential contact areas of the pin, similar to areas 34 as shownin shown in FIG. 1.

FIG. 10 also depicts one embodiment for securing the stackable blocks102. That is, the blocks 102 are secured with an external clip 110 thatconnects the end cap block 16 to the insertion end block 14. In oneimplementation, the clip 110 is a single U-shaped spring that has twoends. The first end is secured at a first attachment point 109 on theend block and the second end is secured at a second attachment point111. The length of the U-shaped clip 110 runs along the outside of thedevice 100 and wraps around the other end block along a channel definedin the other end block, thereby securing the stackable blocks 102together. Alternatively, the external clip 110 may be two C-shapedclips, each having a hook-like feature at each end of the clip. In thisembodiment, there are two attachment points in each end block (insteadof just one end block as shown in FIG. 10) such that one C-shaped clip110 is disposed on one exterior side of the connector 100 and the otherC-shaped clip is disposed on the opposite side and both are attached tothe end blocks with the hook feature.

FIG. 11A depicts a block 102 of the apparatus depicted in FIG. 10. Likethe blocks depicted in FIGS. 4A and 4B, block 102 has C-shaped contactportions 108 disposed within pin receiving portions 104. However, theC-shaped contact portions 108 in this embodiment differ from theC-shaped contact portions 28 described above with respect to FIGS. 3,4A, and 4B. More specifically, the C-shaped contact portions 108 do nothave an unconstrained diameter that is smaller than the OD of the pin.To the contrary, the natural configuration of the C-shaped contactportions 108 in this embodiment have a diameter that is greater than theOD of the pin.

In addition, the block 102 has a cam component 112 disposed in a centralportion of the block 102 such that the cam component 112 is in contactwith each of the pin receiving portions 104. The cam component 112,which is depicted in further detail according to one embodiment in FIGS.12A and 12B (which depict both sides of a cam component 112), has fourindentations 114 and four contact portions 116 around the circumferenceof the component 112. In addition, the component 112 has a drivereceiving component 118 on one side as shown in FIG. 12B and drivecomponent 120 on the other side as shown in FIG. 12A. According to oneembodiment, the drive receiving component 118 is an inset hexagon 118and the drive component 120 is a coupleable hexagon drive component 120.

Each block 102 in this embodiment has a similar cam component 112 suchthat when the blocks 102 are connected to each other, the drivecomponents 120 of each cam component 112 are inserted into the adjacentdrive receiving component 118 on the adjacent block 102, therebyresulting in each of the cam components 112 in each of the blocks 102being connected. In this embodiment, the connected cam components 112may be turned using a tool 122 depicted in FIG. 13, e.g., a wrench suchas a torque wrench.

According to the electrical connection apparatus 100 depicted in FIG.13, the tool 122 is inserted through a central hole 124 defined in theend block 14 and positioned into the drive receiving component 118 ofthe cam component 112 of the block 102 connected to the end block 14,whereby the tool 122 may be used to turn the connected cam components112.

In one embodiment, the tool 122 has on its distal end 126 (the end thatcontacts the drive receiving component 118) certain features that mayimprove torque transmission. According to one embodiment, the featuremay be a shaped end (such as a hexagonal shape, for instance) that isengageable with the drive receiving feature 118 of the cam 112.Additionally, in one implementation, the proximal end 127 of the tool122 may have screw drive features (such as slots, hex, torx, etc.),external knurling, increased circumference flange, or any other knownfeatures for improving torque transmission. In one implementation, theproximal end 127 of tool 122 is configured as a hex driver.

As best depicted in both FIGS. 11A-C, it is understood that theconfiguration of blocks 102 is slightly different from the blocksdepicted in FIGS. 4A and 4B. That is, the slots in blocks 102 have adifferent configuration to accommodate the slightly differentconfiguration of the electrical connection contacts. According to oneembodiment, this configuration allows for a central hole defined in eachof the assembly blocks 102.

In use, the cam component 112 provides for the easy insertion andremoval of the pins. That is, when the cam component 112 is rotatablydisposed such that the four indentations 114 are adjacent to the pinreceiving portions 104 (the “insertion position”), each C-shaped contactportion 108 is disposed at its largest diameter, which is greater thanthe OD of a pin. Thus, when the cam component 112 is in the insertionposition, a pin may easily be inserted into or removed from a pinreceiving portion 104 while experiencing little or no frictional contactwith the C-shaped contact portion 108. Thus, the pin may be inserted orremoved with little or no force.

In contrast, when the cam component 112 is rotatably disposed such thatthe four contact portions 116 are adjacent to the pin receiving portions104 and in contact with the C-shaped contact portions 108 (the “contactposition”), each C-shaped contact portion 108 is urged into contact withthe pin by the force of the contact portion 116 of the cam component112, thereby resulting in electrical contact between the C-shapedcontact portion 108 and the pin. An example of the contact position isdepicted in FIG. 11A. In one embodiment, the C-shaped contact portion108 is in electrical contact with the circumferential contact area ofthe pin similar to the contact area 34 depicted in FIG. 1.

Thus, the tool 122 may be used to turn the connected cam components 112,thereby moving the C-shaped contacts 108 between the insertion positionand the contact position. That is, the tool 122 may be used to turn thecam components 112 such that the contact portions 116 are positioned incontact with the C-shaped contacts 108, thereby urging them into contactwith the pins. In addition to establishing a stable electrical contactinterface between the C-shaped contacts 108 and the pin, the pressure ofthe C-shaped contacts 108 against the pin acts to prevent movement ofthe pin or otherwise secure the pin in its position within the pinreceiving portion 104.

Further, the tool 122 may be used to turn the cam component 112 suchthat the four indentations 114 are in contact with the four C-shapedcontacts 108, thereby allowing each C-shaped contact 108 to expand andto return to the insertion/withdrawal position.

In certain embodiments, after the cams 112 are set to the appropriateposition, the tool 122 may be removed and replaced with a lower profilecap. Alternatively, no cap is provided.

According to one implementation, the combined force of the C-shapedcontacts 108 in contact with the pin creates a sufficiently largemechanical force on the pin such that the pin is not easily dislodged orotherwise disconnected via physical movement of the device 100 or pin.As such, the device 100 may withstand outside physical forces, includingshaking, twisting, and/or other such forces, without disrupting theconnection between the pins and the contact portions 108 as a result ofthe stable configuration of the contact adjustment component 112 andcontact portions 108. As an example, this stability may, in someembodiments, allow a patient requiring such a device 100 to be morephysically active than is possible with known devices. In anotherembodiment, the apparatus 100 may also have a mechanical fastening port(not shown) similar to that described above with respect to FIG. 1,thereby providing further stability.

In the embodiment shown in FIG. 13, an apparatus may provide a tactileresponse to rotation of the cam component 112 such that a user mayproperly position the cam component 112. In one embodiment, the tactileresponse is provided by mated detent features disposed on the drivecomponent 120 of the cam component 112 as shown in FIG. 12A and on theportion of that end block 16 that contacts the cam component 112 asshown in FIG. 13. More specifically, the drive component 120 has femaledetent features 130 shaped as hemispheres formed into the end of thecomponent 120. Further, the end block 16 has male detent features 132shaped as hemispheres that may mate with the female detent features 130.In use, as the cam component 112 is turned, the user may feel the matingand unmating of the detent features and thereby may easily determine theposition of the cam component 112. According to one embodiment, thedetent features 130, 132 are positioned such that the features mate whenthe cam component 112 is positioned in the contact position, such thatthe tactile response of the detent features 130, 132 mating indicates tothe user that the cam component 112 is in the contact position.

In an alternative embodiment, a tactile response is achieved through aset of small indentations (not shown) disposed on the contact portions116 of the cam component 112. These indentations are much smaller andshallower than the indentations 114 and are placed at the optimalcontact points 116 on the cam component 112. These indentations providea tactile response to the user, indicating that the cam component 112 isin the contact position.

In a further embodiment, a visual method of positioning the camcomponent 112 is provided. In this embodiment, alignment markers areplaced on the end block 14 and the top of the cam tool 122.

FIGS. 14A-B depict a first and second perspective view of anotherelectrical connection apparatus 210, according to certainimplementations. The electrical connection apparatus 210 includesstackable blocks 220 arranged between end blocks 240, 260. The assemblyof blocks 220, 240 and 260 may be held together by external spring clip280 or by a U-shaped clip (not shown) with the terminal ends of theU-shaped clip terminating at end block 240. Electrical connectionapparatus 210 may connect two implantable components, e.g., leads and amedical device, in the manner discussed above in relation to theelectrical connection apparatus 10 of FIG. 1. However, according to thepresently described implementation, the electrical connection apparatus210 is configured so that cam action is initiated from one end, e.g.,the end corresponding to end block 240, and pins enter from another endof apparatus 210, e.g., the end corresponding to end block 260. Thisembodiment may provide certain advantages because, due to the smallallowable space for active implantable devices and the small sizing ofthe electrical connectors, placing leads at one end of the device androtating the cam at the opposite end may reduce the chance ofentanglement between the leads and the rotating mechanism, hands, tool,torque wrench, etc., during manual rotation or operation of the cam.

FIGS. 15A-F depict perspective views of a first and second side of afirst end block 240, a stackable block 220 and a second end block 260 ofapparatus 210 shown in FIGS. 14A-B.

In FIGS. 15A-B, end block 240 is configured with grooves 241 on oppositesides of the block for accommodating external clip 280, an opening 242,which provides access to a cam or other adjustment component (not shown)situated in an adjacent stackable block 220, and receivers 243 forreceiving retaining clips 222 arranged on stackable block 220 (shown inFIG. 15C). End block 240 serves as an access point for accessing a camor other adjustment component arranged on the interior of the assembledapparatus 210 and may have a configuration similar to insertion endblock 14 of FIG. 1, except that end block 240 does not include the pinreceiving portions described in relation to FIG. 1.

FIGS. 15C-D depict perspective views of a first and second side of astackable block 220. In FIGS. 15C-D, block 220 includes grooves 221,retaining clip 222, receivers 222′ for retaining clips 222, knife edges223, slots 224, potting pockets 225, cam receiving portion 226, camdetents 227, cam hard stops 228 and pin receiving portions 229. Grooves221 on opposite sides of the block accommodate spring clip 280 and mayfacilitate maintaining the desired positioning of spring clip 280 on theassembled apparatus 210. Retaining clips 222 arranged near the peripheryof an interior facing portion of block 220 may facilitate holding seals250 in place (See FIG. 21A) and may aid in assembly of adjacent blocks,e.g., adjacent end blocks 240, 260 or other stackable blocks 220. Forexample, during assembly, retaining clips 222 may engage with receivers222′ arranged near the periphery of an interior facing portion ofanother block 220 or from receivers 243 arranged near the periphery ofan interior facing portion of an adjacent end block 240. Knife edges 223provided on stackable blocks 220 may facilitate providing a seal betweenseal plate 250 and stackable blocks 220.

Each stackable block includes four slots 224 for providing an electricalconnection contact (not shown) access to the exterior of the block 220.Four potting pockets 225 are arranged in an area proximate the slot 224and may accommodate an epoxy or other polymeric resin, which may sealslots 224 and prevent moisture ingress to the interior of apparatus 210.Cam receiving portion 226 is defined by interior walls of stackableblock 220 and is configured to receive a cam (not shown) or otheradjustment component and includes cam hard stops 228 that cooperate withthe cam 330 and serve as stop points for the cam rotating from a lockingor contact to an unlocking or insertion position. Cam detents 227 arearranged adjacent the cam hard stops 228 and serve as an indicator to auser rotating the cam that the cam has reached a locking or contactposition or an unlocking or insertion position. Four pin receivingportions 229 are each configured to accept a pin (not shown) and aredefined by interior walls of stackable block 220.

FIGS. 15E-F depict perspective views of a first and second side of asecond end block 260, which may be configured similar to end cap block16 described in relation to FIG. 1, except that end block 260 mayinclude pin receiving portions and/or fastening ports similar to thoseprovided in insertion end block 14. End block 260 also includes a groove261 for accommodating external spring clip 280 or a U-shaped spring thatwould traverse exterior of the second end block along the length of thegroove.

FIGS. 16A-B depict perspective views of a first and second side of thestackable block 220 with a pin 300 inserted through the block. FIG. 16Adepicts a drive component of cam 330 in an insertion position. FIG. 16Bdepicts the assembly from the back side and the cam 330 with the drivereceiving component is set in the open or initial insertion position.

FIG. 17A depicts one of the contact assemblies in the unlocked position.The cam 330 is loosely coupled to a slider 350, which is mechanicallyengaged to an electrical connection contact 340 via a tab 342 (see FIG.19A). In the unlocked position, slider 350 is in a lowered positionrelative to the periphery of stackable block 220 and loosely engagedwith electrical connection contact 340. Electrical connection contact340 is in a relaxed state, and as a result, pin 300 arranged in block220 may be slidable through the C-shaped connection 346 in the contact340. Thus, in FIG. 17A, the cam 330, slider 350 and tab 342 are in aninsertion position, and a pin may be inserted into or removed from a pinreceiving portion 229 while experiencing little or no frictional contactwith the C-shaped contact portion 346, resulting in the pin beinginsertable or removable with little or with zero insertion force.

In FIG. 17B, a first side of the contact assembly is shown in its lockedposition. Cam 330 has raised the position of slider 350 and C-shapedcontact portion 346 is clinched around pin 300 at anelectrically-isolated circumferential contact 304. As a result, when cam330 is in a locked position, pin 300 is locked into position about itscircumferential contact 304 by the reduction of the circumference of theC-shaped portion of electrical C-shaped contact 346. This actioncompletes the electrical path from the external contacts 344 through theC-shaped contact 346 to the isolated pin contact 304 to the internal pinlead 30 (see FIG. 1). When four pins 300 are provided in apparatus 210,each slider 350 is responsible for raising the position of two tabs 342,362 (see FIGS. 19A and B), which in turns clinches two of the four pins300. Providing sliders 350 that engage with tabs 342, 362 to cause theC-shaped contacts 346 to tighten around and couple to pins 300 inresponse to cam action, according to the present implementation, mayreduce or prevent buckling of the C-shaped portion 346, 366 of theelectrical connection contacts 340, 360.

According to FIG. 17B, in addition to establishing a stable electricalcontact interface between the C-shaped contacts 346 and the pin 300, thepressure of the C-shaped contacts 346 against pin 300, due to thepositioning of slider 350 in a contact position, may prevent movement ofthe pin or secure the pin in its position within the pin receivingportion 229. The force of the C-shaped contact 346 in contact with thepin may provide a sufficiently large mechanical force on the pin suchthat the pin may not be dislodged or dislodged easily, or otherwisedisconnected via physical movement of the device 210 or pin 300. Thus,the device 210 may withstand outside physical forces, including shaking,twisting, and/or other such forces, without disrupting the connectionbetween the pins and the contact portions 346 as a result of the stableconfiguration of the cam 330, slider 350 and tab 342.

FIGS. 18A-B depict perspective views of a first and second side of cam330. Cam 330 includes a drive component 331, eccentric paths 332 forsliders 350, detent feature 333 and a drive receiving component 334. InFIG. 18A, the drive component 331 having a tapered hexagonal maleportion is configured such that it fits into an adjacent cam by way of acomplementary drive receiving component 334 having a tapered hexagonalfemale receiving configuration. When cam 330 is arranged in block 220,the drive component 331 protrudes beyond the an exterior surface ofblock 220, see e.g., FIGS. 16A and 17A. Eccentric paths 332 for slider350 may be configured so that when cam 330 is arranged in block 220,eccentric paths 332 loosely couple to the sliders 350 when in aninsertion or unlocked position, and moves sliders 350 up or down when ina contact or locked position. Detent feature 333 engages with camdetents 227 of block 220 when cam 330 is moved to either a locked or anunlocked position. When detent feature 333 reaches one of the camdetents 227, a user exerting torque, e.g., by way of a tool such as awrench or a torque wrench, on the cam assembly may feel detent feature333 engage with the cam detent. Where a user continues to exert torqueon the cam assembly after the detent feature 333 engages with camdetent, detent feature 333 may abut an adjacent cam of the pair of camhard stops 228 provided on block 220 preventing cams from furtherrotational movement. In use, cams 330 from adjacent blocks 220 interlockvia the drive and drive receiving components 331, 334, respectively.Accordingly, actuation of a cam 330 arranged in a stackable block 220adjacent to end block 240 results in actuation of each of the cams 330arranged in the electrical connection apparatus 210. Furthermore,because detents 227 and hard stops 228 in stackable block 220 cooperatewith cam 330, initiating cam action with a torque wrench may provide forprecise engagement and rotation of cams 330 within electrical connectionapparatus 110.

FIGS. 19A-B depict perspective views of electrical connection contact340, 360 for use on a left and a right side of the stackable block 220.FIGS. 20A-B depict perspective views of a first and second side of aslider 350 for use with the stackable block 220 and include recesses 351and 352 for engaging with electrical connection contact 340, 360.According to certain implementations, sliders 350 may be constructed ofplastic, ceramic, other insulating material, or may be coated with aninsulating material.

With reference to FIG. 19A, a left side electrical connection contact340 includes tab 342 for engaging with slider recess 351, exteriorcontact portion 344 for contacting an external device and for aligningalong an exterior length of the stackable block 220, and C-shapedinterior contact portion 346 for aligning with pin receiving portion 229and for contacting pin 300. In FIG. 19B, a right side electricalconnection contact 360 includes tab 362 configured for engaging withslider recess 351, exterior contact portion 364 for contacting anexternal device, and C-shaped interior contact portion 366 for aligningwith pin receiving portion 229 and contacting pin 300. Tab 342, 362provides slider recess 351 with a desirable length of the electricalconnection contact 340, 360 such that the contact may be moved from aninsertion to a contact position as a result of an upward or downwardmovement of the slider 350. Electrical connection contacts 340, 360 mayalso include features described above in relation to the electricalconnection contacts of FIGS. 3A-B, 5A-G and 11.

FIGS. 21A-B depict perspective views of a first and second side of thestackable block 220. FIGS. 22A-B depict perspective views of a first andsecond side of a seal component 250, which may be arranged on stackableblock 220 at a position corresponding to the recessed portion R of sealblock 220 depicted in FIG. 21A. Assembled electrical connectionapparatus 210 (FIGS. 14A-B) may be provided with a seal component 250between each block, e.g. between end block 240 and stackable block 220,between stackable blocks 220, and between stackable block 220 and endblock 260 in order to prevent biological fluids from contacting pins300, for example. In addition, stackable blocks 220 associated with thepresently described apparatus 210 include clips 222, which mayfacilitate holding seal component 250 in place as well as engage withreceivers 222′, as shown in FIG. 21B. Moreover, knife edges 223 providedon stackable block 220 in the areas corresponding to the cam receivingportion 226, pin receiving portions 229, and an area surrounding each ofthe cam and pin receiving portions. Knife edges 223 may mate withvertical seal portions provided on seal component, which are shown anddescribed in relation to FIG. 7.

FIGS. 23A-B depict a first and second perspective view of anotherelectrical connection apparatus 410 having a two pin configuration.Electrical connection apparatus 410 may otherwise be configured in amanner similar to that of electrical connection apparatus 10, 80, 100,and 210.

In certain implementations, all or a portion of electrical connectionapparatus 10, 80, 100, 210 and 410 may be over-molded in silicone oranother polymer in order to reduce or eliminate the chance of moistureingress. In addition, in certain implementations, pin 20 and pin 300 mayhave a variety of diameters and configurations. For example, pinscoupled to leads that deliver electrical pulses may be larger than pinscoupled to sensing leads. Accordingly, the pin receiving portions ofapparatus 10, 80, 100, 210 and/or 410 may be configured to accept a pinhaving a desirable cross-section or configuration.

FIG. 24 is a flowchart of a method (500) for electrically connecting animplanted medical device and an implanted stimulation electrodeaccording to the present invention. According to FIG. 24, method (500)includes providing (510) a connection device having at least onestackable block and a first end block and a second end block arranged ona first and a second end of the at least one stackable block, where eachof the at least one stackable block includes at least one pin receivingportion, and at least one electrical connection contact. Method (500)also includes inserting (520) a pin into at least one pin receivingportion such that the pin is electrically coupled to an implantedmedical device or to an implanted stimulation electrode, andelectrically coupling (530) to the lead portion the other of theimplanted medical device or the implanted stimulation electrode.

According to certain embodiments, the electrical connection apparatuspassageway through which the proximal end of the lead must pass, withits exposed conductive surfaces in segments along its longitudinal axis,has a series of actively engageable seals or barriers alternatinglongitudinally with the conductive surfaces in the receptacle. Whenengaged, the active seals block the incursion of fluid along the lead'spath, and prevent the migration of fluid from the region of oneconductive surface in the receptacle to any other, and in the instancewhere there are already existing fluid bridges between conductors,forces the fluid out and breaks the electrical pathway.

FIG. 25 is an isometric view of an active seal, according to certainembodiments. A single lead lumen is shown for clarity; but a pluralityof lead lumens may also be provided in a single seal. The figure depictsa fluid seal 600 with a substantially planar body 601. The perimeter 606of the body 601 may be captured and compressed to form a boundary seal.The seal incorporates a cylindrical extension, or seal tube 602, whichhas a lumen defining a pin receiving portion with diameter just largeenough to permit passage of a lead 608 with little or no clearance.According to certain embodiments, the seal tube 602 is surrounded at onepoint by a metallic ring or cinch 603 that can be reduced in diameter inorder to reduce the diameter of the seal tube 602 around the lead 608.According to FIG. 25, the cinch 603 includes fixed position tabs 604 atone terminal end, which are captured by part of the housing of theconnector block (see, e.g., FIG. 27A). The other, opposite end of thecinch 603 comprises a moveable tab or tabs 605, which is/are engaged bya moving a mechanism pushed by a cam (see, e.g., FIGS. 27A-27C).Moveable tab 605 is forced towards and past fixed position tabs 604,thus reducing the diameter of the cinch 603. This compresses thematerial of the seal tube 602, which then is pressed tightly to theouter surface of the lead 608. Of course, both tabs may be movabletowards and away from each other in order to constrict and relax thecinch 603.

FIG. 26 depicts a proximal end of an implanted lead 608. The body of thelead comprises an insulating flexible polymer with internal conductors.At the proximal end, the conductors are exposed by means of externalmetal contacts such as rings 609, with sections of insulator 610 betweenthem to isolate them from each other. This proximal end of the implantedlead, commonly called a “pin” is the portion of the lead which entersthe connector block. Dummy pins are also used which have the samediameter and proximal length as the lead pin. These dummy pins fit intothe seal tubes 602 of FIG. 25, when the surgical scenario does notpresent with a sufficient number of lead pins to fill all the seal tubeson a device.

FIG. 27A is an isometric view of a two lumen 611 active sealincorporating a controlling mechanism, according to certain embodiments.The seal is composed of a base or body 601, which includes two lead portseal tubes 602 with pin receiving portions formed of lumens 611 toaccept passage of a lead 608. A separate moving element of the structureis a rotating cam 612. As the cam 612 is rotated, the ramp 613 on thesurface of the cam 612 contacts and moves a slider 614. Further rotationof the cam 612 will then force the slider 614 to rotate around its fixedanchor point 615 in the plastic block (not shown). The opposite end ofthe slider 614 contains a slot 616, which entraps the moveable tab 605of the seal's cinch 603 (See FIG. 25). Moving the moveable tab 605 ofthe cinch 603 engages or activates the seal by compressing seal tube 602outer diameter to a smaller dimension. In this state, the lead'sconductive surfaces are isolated and the lead 608 is held in place bythe increased frictional forces. The activated seal also fluidlyisolates adjacent electrical connection contacts from each other. As aresult, the lead conductive surface with its associated electricalconnection contact together are fluidly isolated from other adjacentelectrical connections and stackable blocks.

According to FIG. 27A, the cam 612 comprises a shaped opening 617 at itscenter. This opening 617 accommodates the central shaft (See, e.g., FIG.28) having a shape complementary to the opening 617 so that whenrotated, the shaft forces the cam 612 to rotate. Once the mechanismrotates the cam 612 to its fully engaged position, it will remain inthat position. Reverse rotation of the cam 612 will relax the forces onthe slider 614, allowing the spring forces from the metallic cinch 603,to expand the cinch 603 and release the seal. In this relaxed state, thelead 608 can move freely.

FIG. 27B is a magnified view of the active seal mechanism. The lead 608can be seen inserted into one of the lumens 611 of the seal 601. The cam612, in this instance, is not yet pressing against the slider 614.However, the slider 614, still grasps the moveable tab 605 of the cinch.The fixed position tabs 604 of the cinch are visible in their retainedposition.

FIG. 27C is a magnified view of the active seal mechanism with the cam612 rotated to the latched position. Slider 614 is moved maximally toforce the moveable tab 605 so that the cinch has its smallest diameterand tightly grasps the lead body 608. Fixed position tab 604 remainsfixed to its position, retained in place by in the block(not shown).

According to certain embodiments, the cam 612 and/or the slider 614 mayalso be associated with a portion of an electrical connection contactsuch as tab 342, 362. In this embodiment, a stackable block, e.g., block220, may include both the seal 600 as well as the electrical connectioncontacts 340, 360. Rotation of a shaft associated with cam 612 and/orslider 614 may result in engagement of the seals and the electricalconnection contacts. That is, the same controlling mechanism may beresponsible for engaging both the seals and the electrical contacts(See, e.g., FIG. 28A). Accordingly, rotating cam 612 may rotate slider614 causing each of the movable tab 605 and one or more of tabs 342, 362provided on electrical connection contacts 340 and 360 to rotate into anactivated position. In other embodiments, separate rotatable cams areassociated with each of the electrical contacts and the seals, and eachcam is responsible for causing its corresponding seal or electricalconnection contact to move between the active and relaxed positions(See, e.g., FIG. 28B). For example, one stackable block 220 may beassociated with an electrical connection contact 340, 360 and a cam 330for controlling the diameter of the contact, while another stackableblock 622 may be associated with a seal 600 and a cam 612, and thestackable blocks 220, 622 may be operably coupled to one another. As aresult, in an active seal state, the seal 600 fluidly isolates theelectrical connection contact in the adjacent stackable block 220 fromthe stackable block 622 having the seal 600.

FIG. 28A is a cross-sectional view of a connector block assembly for animplantable device, according to certain embodiments. The examples ofleads 608 show conductors as three rings 609 and an end pin 624 on eachlead 608. The lead 608 is shown inserted into the connector assemblywhich is comprised of a plurality of blocks 622, which sandwich activeseals, e.g., including seal tubes 602, between the blocks. Along thebody of the lead 608, the seals partition the electrical contacts 621,which connect to the lead's conductors 609, 624 into separate isolatedsections. The centrally located activating shaft 625, which powers thecam 612 of FIG. 27A, runs the full length of the assembly. In FIG. 28A,rotation of a shaft associated with cam 612 and/or slider 614 may resultin engagement of the seals and the electrical connection contacts. FIG.28B is a cross-sectional view of a connector block assembly for animplantable device having separate controlling mechanisms such as cam612 and cam 330 for engaging seals and electrical contacts, according tocertain embodiments, and as described above.

FIG. 29 is a schematic of a cross section of a connector block 630showing an alternative driving mechanism. The connector block 630incorporates a seal 600 in one or more places. The cinch 603 with itsattached moveable tab 605 surrounds the seal tube 602 as in previousfigures. The connector block 630 body is penetrated by a threaded screwhole 631 that allows a screw 632 to travel from the outer edge of theconnector 630 and impinge on the moveable tab 605. Further travel of thescrew 632 will then force the tab 605 to move. The moveable tab 605movement will reduce the diameter of the cinch 603 and compress the sealtube 602 in a manner similar to that depicted in FIGS. 27A and 27B. Thescrew serves as an alterative forcing structure to actuate the seal.Release of the seal tube's 602 compression is accomplished by reversingand removing the screw 632.

Additionally, according to certain embodiments, the active forces of theseal may isolate intentional fluids introduced in the body of theconnector. Intentional fluids may include dielectric fluids such asmineral oil or mixtures containing mineral oil and may be included in,for example, pin receiving portions in order to provide lubricatingproperties, which may reduce the friction between the pin and innersurface of the seal tube and/or the electrical connection contact, thusreducing insertion forces. The intentional fluid may also serve as ahydrophobic fluid to oppose the intrusion of body fluids and otherfluids, as an insulator by incorporating an intentional fluid with anappropriate dielectric coefficient, and/or as an isolator for isolatingone contact from another. The intentional fluid may be a cleaning agentfor dissolving organic debris such as blood. An antimicrobial chemicalmay be emulsified or dissolved into the fluid to prevent the growth ofinfectious entities such as bacteria or viruses on internal surfaces ofthe electrical connection apparatus or on the outer surface of the pin.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, theinvention is capable of modifications in various obvious aspects, allwithout departing from the spirit and scope of the present invention.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

Although the present invention has been described with reference topreferred embodiments, persons skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

1. An electrical connection apparatus comprising: (a) at least onestackable block, wherein each stackable block is operably coupleable toanother stackable block; (b) at least one pin receiving portion definedby an inner wall within the at least one stackable block; (c) at leastone electrical connection contact comprising a first portion disposedwithin the at least one pin receiving portion of the at least onestackable block, the first portion for receiving a pin, and a secondportion disposed at a location exterior to the stackable block, whereinthe first portion and the second portion integrally form the at leastone electrical connection contact; and (d) a fluid seal arranged in thestackable block adjacent to the electrical connection contact, the fluidseal comprising: (i) a seal tube defining a pin receiving portion forreceiving the pin; and (ii) a cinch for reducing the diameter of theseal tube around the pin; wherein when the diameter of the seal tube isreduced around a diameter of the pin, the seal tube fluidly isolates theat least one electrical connection contact associated with one stackableblock from another electrical connection contact associated with theanother stackable block.
 2. The apparatus of claim 1, wherein the cinchfurther comprises a movable tab and a fixed tab arranged at opposingterminal ends of the cinch, and wherein the movable tab moves to reducethe diameter of the seal tube.
 3. The apparatus of claim 2, wherein thefixed tab is fixed to the stackable block in which the fluid seal isarranged.
 4. The apparatus of claim 2, wherein the movable tab iscoupled to a slider rotatably arranged in the stackable block, whichrotates around a fixed anchor point and moves the movable tab to reducethe diameter of the seal tube.
 5. The apparatus of claim 2, furthercomprising a rotatable cam rotatably arranged in the stackable block andassociated with the movable tab, wherein rotation of the rotatable cammoves the movable tab to reduce the diameter of the seal tube.
 6. Theapparatus of claim 5, wherein an activating shaft runs longitudinallyalong a length of the electrical connection apparatus and is received bythe rotatable cam, wherein the activating shaft rotates the rotatablecam thereby causing the movable tab to reduce the diameter of the sealtube.
 7. The apparatus of claim 5, wherein the rotatable cam isassociated with the movable tab via a slider, and rotating the rotatablecam rotates the slider.
 8. The apparatus of claim 5, wherein therotatable cam is further associated with the first portion of theelectrical connection contact, and rotation of the rotatable cam reducesa diameter of the first portion of the electrical connection contact toestablish an electrical connection between the pin and the at least oneelectrical connection contact.
 9. The apparatus of claim 8, wherein therotatable cam is associated with each of the movable tab and the firstportion of the electrical connection contact via a slider, and rotatingthe rotatable cam rotates the slider.
 10. The apparatus of claim 2,wherein the movable tab is coupled to a screw movably disposed in asidewall of the at least one stackable block, wherein actuating thescrew moves the movable tab.
 11. The apparatus of claim 1, furthercomprising a dielectric fluid disposed at least in the first portion ofthe electrical connection contact and the pin receiving portion of theat least one fluid seal.
 12. An electrical connection apparatuscomprising: (a) a plurality of stackable blocks, wherein each stackableblock is operably coupleable to another stackable block; (b) at leastone pin receiving portion defined by an inner wall within one of theplurality of stackable blocks; (c) at least one electrical connectioncontact comprising a first portion disposed within the at least one pinreceiving portion of the one stackable block, the first portion forreceiving a pin, and a second portion disposed at a location exterior tothe one stackable block, wherein the first portion and the secondportion integrally form the at least one electrical connection contact;and (d) a fluid seal arranged in another of the plurality of stackableblocks, the fluid seal comprising: (i) a seal tube defining a pinreceiving portion for receiving the pin; and (ii) a cinch for reducingthe diameter of the seal tube around the pin; wherein when the diameterof the seal tube is reduced around a diameter of the pin, the seal tubefluidly isolates the at least one electrical connection contactassociated with the one stackable block from the another stackable blockhaving the fluid seal.
 13. The apparatus of claim 12, wherein the cinchfurther comprises a movable tab and a fixed tab arranged at opposingterminal ends of the cinch, and wherein the movable tab moves to reducethe diameter of the seal tube.
 14. The apparatus of claim 13, whereinthe fixed tab is fixed to the another stackable block in which the fluidseal is arranged.
 15. The apparatus of claim 13, wherein the movable tabis coupled to a slider rotatably arranged in the another of theplurality of stackable blocks, which rotates around a fixed anchor pointand moves the movable tab to reduce the diameter of the seal tube. 16.The apparatus of claim 13, further comprising a rotatable cam rotatablyarranged in the another of the plurality of stackable blocks andassociated with the movable tab, wherein rotation of the rotatable cammoves the movable tab to reduce the diameter of the seal tube.
 17. Theapparatus of claim 16, wherein an activating shaft runs longitudinallyalong a length of the electrical connection apparatus and is received bythe rotatable cam, wherein the activating shaft rotates the rotatablecam thereby causing the movable tab to reduce the diameter of the sealtube.
 18. The apparatus of claim 16, wherein the rotatable cam isassociated with the movable tab via a slider, and rotating the rotatablecam rotates the slider.
 19. The apparatus of claim 16, furthercomprising another rotatable cam, the another rotatable cam arranged inthe one stackable block and associated with the first portion of theelectrical connection contact of the one stackable block, and rotationof the another rotatable cam reduces a diameter of the first portion ofthe electrical connection contact to establish an electrical connectionbetween the pin and the at least one electrical connection contact. 20.The apparatus of claim 12, further comprising a dielectric fluiddisposed at least in the first portion of the electrical connectioncontact and the pin receiving portion of the fluid seal.